Compositions and methods for enhancing therapeutic effects

ABSTRACT

Compositions and methods for enhancing the effects of therapeutic compositions are provided. The compositions comprise singly or in combination herbals, natural nutritional supplements, minerals and vitamins.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional ApplicationSerial No. 60/208,990, filed Jun. 1, 2000, hereby incorporated in itsentirety by reference.

TECHNICAL FIELD

This invention relates to compositions and methods for enhancingtherapeutic effects. More specifically, it relates to nutraceuticalcompositions for enhancing the therapeutic effects of anothercomposition, and methods for enhancing therapeutic effects.

BACKGROUND ART

The need for enhancement of therapeutic effects of therapeuticsubstances or compositions is particularly apparent where conventionalherbal and natural nutritional supplements are used to achieve theseeffects. These substances act slowly, and are considered primarily toprovide individuals with long term benefits rather than short term orimmediate improvement in the medical condition in question. Althoughpharmaceutical drugs have generally been considered to be more effectivein treating acute conditions, this treatment often has significant sideeffects. Non-pharmaceutical alternatives, such as nutraceuticals, areoften preferred because of their safer or more long-lasting effects.This usually means, however, that in choosing these alternativeapproaches, the treated individual has to forego more immediatealleviation of symptoms that might otherwise have been achievablethrough the use of pharmaceuticals.

It would, therefore, clearly be advantageous to have herbal and naturalnutritional supplements that can provide therapeutic effects similar inintensity and immediacy to pharmaceutical drugs, while continuing toprovide long term health benefits and with the avoidance of significantside effects. The invention described and claimed in this specificationprovides this advantage by presenting compositions and methods forenhancing the therapeutic effects of conventional herbal and naturalnutritional supplements.

All references cited herein, including patent applications andpublications, are incorporated by reference in their entirety.

DISCLOSURE OF THE INVENTION

Compositions and methods for enhancing effects of therapeuticcompositions are provided. The compositions comprise substances inquantities that are effective for enhancing the therapeutic effects ofcompositions with which they are administered in combination. Methods ofenhancing therapeutic effects of a composition comprising administrationof the claimed compositions are also provided. Methods of makingcompositions of the invention are also provided.

Accordingly, in one aspect, the invention provides a first compositionfor enhancing the therapeutic effects of a second composition, saidfirst composition comprising a substance selected from the groupconsisting of a member of the botanical group Daemonorops and a memberof the botanical group Corydalis.

In another aspect, the invention provides a first composition forenhancing the therapeutic effects of a second composition, said firstcomposition comprising a member of the botanical group Daemonorops and amember of the botanical group Corydalis.

In one embodiment, the invention provides a composition selected from agroup consisting of the first compositions of the aspects of theinvention described in the preceding paragraphs, further comprising asubstance selected from the group consisting of a member of thebotanical group Paeonia, a member of the botanical group Panax, a memberof the botanical group glycyrrhiza, white willow bark, a member of thebotanical group Cimicifuga, L-carnitine, vitamin E and vitamin C. Thus,for example, in one embodiment, a composition comprises a member of thebotanical group Daemonorops and a member of the botanical group Panax.In some of these embodiments, the composition comprises xuejie andshanqi. In another example, a composition comprises a member of thebotanical group Corydalis and a member of the botanical group Panax. Insome of these embodiments, the member of the botanical group Corydalisis yanhusuo and the member of the botanical group Panax is shanqi.

In another embodiment, the invention provides a composition selectedfrom a group consisting of the aspects of the invention described in thepreceding paragraphs, further comprising 2 substances selected from thegroup consisting of a member of the botanical group Paeonia, a member ofthe botanical group Panax, a member of the botanical group glycyrrhiza,white willow bark, a member of the botanical group Cimicifuga,L-camitine, vitamin E and vitamin C.

In another embodiment, the invention provides a composition selectedfrom a group consisting of the aspects of the invention described in thepreceding paragraphs, further comprising 3 substances selected from thegroup consisting of a member of the botanical group Paeonia, a member ofthe botanical group Panax, a member of the botanical group glycyrrhiza,white willow bark, a member of the botanical group Cimicifuga,L-camitine, vitamin E and vitamin C.

In another embodiment, the invention provides a composition selectedfrom a group consisting of the aspects of the invention described in thepreceding paragraphs, further comprising 4 substances selected from thegroup consisting of a member of the botanical group Paeonia, a member ofthe botanical group Panax, a member of the botanical group glycyrrhiza,white willow bark, a member of the botanical group Cimicifuga,L-camitine, vitamin E and vitamin C.

In another embodiment, the invention provides a composition selectedfrom a group consisting of the aspects of the invention described in thepreceding paragraphs, further comprising 5 substances selected from thegroup consisting of a member of the botanical group Paeonia, a member ofthe botanical group Panax, a member of the botanical group glycyrrhiza,white willow bark, a member of the botanical group Cimicifuga,L-carnitine, vitamin E and vitamin C.

In another embodiment, the invention provides a composition selectedfrom a group consisting of the aspects of the invention described in thepreceding paragraphs, further comprising 6 substances selected from thegroup consisting of a member of the botanical group Paeonia, a member ofthe botanical group Panax, a member of the botanical group glycyrrhiza,white willow bark, a member of the botanical group Cimici fuga,L-camitine, vitamin E and vitamin C.

In another embodiment, the invention provides a composition selectedfrom a group consisting of the aspects of the invention described in thepreceding paragraphs, further comprising 7 substances selected from thegroup consisting of a member of the botanical group Paeonia, a member ofthe botanical group Panax, a member of the botanical group glycyrrhiza,white willow bark, a member of the botanical group Cimicifuga,L-carnitine, vitamin E and vitamin C.

In another embodiment, the invention provides a composition selectedfrom a group consisting of the aspects of the invention described in thepreceding paragraphs, further comprising a member of the botanical groupPaeonia, a member of the botanical group Panax, a member of thebotanical group glycyrrhiza, white willow bark, a member of thebotanical group Cimicifuga, L-camitine, vitamin E and vitamin C.

In some embodiments of the compositions of the aspects of the invention.described in the preceding paragraphs, the member of the botanical groupDaemonorops is xuejie and/or the member of the botanical group Corydalisis yanhusuo. In some embodiments of the compositions of the aspects andembodiments of the invention described in the preceding paragraphs, themember of the botanical group Daemonorops is xuejie, the member of thebotanical group Corydalis is yanhusuo, the member of the botanical groupPaeonia is baishaoyao, the member of the botanical group Panax isshanqi, the member of the botanical group glycyrrhiza is gancao, and/orthe member of the botanical group Cimicifuga is black cohosh.

Accordingly, in one aspect, the invention provides a first compositionfor enhancing the therapeutic effects of a second composition, saidfirst composition comprising a substance selected from the groupconsisting of xuejie and yanhusuo.

In another aspect, the invention provides a first composition forenhancing the therapeutic effects of a second composition, said firstcomposition comprising xuejie and yanhusuo.

In one embodiment, the invention provides a composition selected fromthe group consisting of the first compositions of the aspects of theinvention described in the preceding paragraphs, further comprising asubstance selected from the group consisting of baishaoyao, shanqi,gancao, white willow bark, black cohosh root, L-carnitine, vitamin E andvitamin C.

In another embodiment, the invention provides a composition selectedfrom the group consisting of the first compositions of the aspects ofthe invention described in the preceding paragraphs, further comprising2 substances selected from the group consisting of baishaoyao, shanqi,gancao, white willow bark, black cohosh root, L-camitine, vitamin E andvitamin C.

In another embodiment, the invention provides a composition selectedfrom a group consisting of the first compositions of aspects of theinvention described in the preceding paragraphs, further comprising 3substances selected from the group consisting of baishaoyao, shanqi,gancao, white willow bark, black cohosh root, L-camitine, vitamin E andvitamin C.

In another embodiment, the invention provides a composition selectedfrom the group consisting of the first compositions of the aspects ofthe invention described in the preceding paragraphs, further comprising4 substances selected from the group consisting of baishaoyao, shanqi,gancao, white willow bark, black cohosh root, L-carnitine, vitamin E andvitamin C.

In another embodiment, the invention provides a composition selectedfrom the group consisting of the first compositions of the aspects ofthe invention described in the preceding paragraphs, further comprising5 substances selected from the group consisting of baishaoyao, shanqi,gancao, white willow bark, black cohosh root, L-camitine, vitamin E andvitamin C.

In another embodiment, the invention provides a composition selectedfrom the group consisting of the first compositions of the aspects ofthe invention described in the preceding paragraphs, further comprising6 substances selected from the group consisting of baishaoyao, shanqi,gancao, white willow bark, black cohosh root, L-carnitine, vitamin E andvitamin C.

In another embodiment, the invention provides a composition selectedfrom the group consisting of the first compositions of the aspects ofthe invention described in the preceding paragraphs, further comprising7 substances selected from the group consisting of baishaoyao, shanqi,gancao, white willow bark, black cohosh root, L-camitine, vitamin E andvitamin C.

In another embodiment, the invention provides a composition selectedfrom the group consisting of the first compositions of the aspects ofthe invention described in the preceding paragraphs, further comprisingbaishaoyao, shanqi, gancao, white willow bark, black cohosh root,L-carnitine, vitamin E and vitamin C.

In one embodiment, the invention provides a first composition forenhancing therapeutic effects of a second composition comprising xuejie,yanhusuo, baishaoyao, shanqi, gancao, white willow bark, black cohoshroot, L-carnitine, vitamin E and vitamin C.

In some embodiments of the compositions of the invention describedherein, said compositions further comprise zinc and/or selenium.

In various aspects and embodiments of the compositions of the invention,the second composition whose therapeutic effects are enhanced by thecompositions of the invention is effective for treating a conditionselected from the group consisting of an eye discomfort condition, awrist discomfort condition, a neck and shoulder discomfort condition,and a back and leg discomfort condition. In some embodiments,compositions of the invention are effective for enhancing cellularmetabolism. In some embodiments, the compositions of the invention areeffective for enhancing blood circulation, reducing cellular/tissueinflammation and/or reducing pain.

In one aspect, the invention provides methods for enhancing effects of atherapeutic composition comprising co-administering an effective amountof a composition selected from the group consisting of the compositionsof the invention disclosed in the preceding paragraphs with saidtherapeutic composition, whereby the effects of said therapeuticcomposition are enhanced.

In still another aspect, the invention provides methods of making acomposition for enhancing effects of a therapeutic composition, saidmethod comprising combining at least one (for example, 1 or 2) substance(preferably in an effective amount) selected from the group consistingof a member of the botanical group Daemonorops and a member of thebotanical group Corydalis with at least one (preferably 1, 2, 3, 4, 5,6, 7 or 8) substance (preferably in an effective amount) selected fromthe group consisting of a member of the botanical group Paeonia, amember of the botanical group Panax, a member of the botanical groupglycyrrhiza, white willow bark, a member of the botanical groupCimicifuga, L-camitine, vitamin E and vitamin C. In some embodiments,the methods comprise combining a member of the botanical groupDaemonorops and a member of the botanical group Corydalis. In variousembodiments of the these methods, the member of the botanical groupDaemonorops is xuejie, the member of the botanical group Corydalis isyanhusuo, the member of the botanical group Paeonia is baishaoyao, themember of the botanical group Panax is shanqi, the member of thebotanical group glycyrrhiza is gancao, and/or the member of thebotanical group Cimicifuga is black cohosh. In some embodiments, saidcombining is by mixing (such as by stirring, agitation or vibration). Insome embodiments, the substances are packaged in the form of capsules,preferably in size “0”, “00”, “000”, “1”, “2”, “3” or “4.” In yet otherembodiments, the substances are combined in powder form, preferably toat least 30%, 60%, or 90% mixture consistency, or to homogeneity.

MODES FOR CARRYING OUT THE INVENTION

The present invention discloses compositions comprising single ormultiple substances that are effective and safe for enhancing thetherapeutic effects of another composition when administered incombination. The invention further provides methods for enhancingtherapeutic effects of compositions comprising co-administering thecompositions of this invention with a therapeutic composition.

Definitions

The term “treating,” “treatment,” and variations thereof, as used inthis specification, refers to an approach for obtaining beneficial ordesired physiological results, which may be established clinically. Forpurposes of this invention, beneficial or desired clinical resultsinclude, but are not limited to, alleviation of symptoms, diminishmentof extent of disease, stabilized (i.e., not worsening) condition, delayor slowing of progression or worsening of condition/symptoms,amelioration or palliation of the condition or symptoms, and remission(whether partial or total), whether detectable or undetectable. The term“palliation”, and variations thereof, as used herein, means that theextent and/or undesirable manifestations of a physiological condition orsymptom are lessened and/or time course of the progression is slowed orlengthened, as compared to not administering compositions of the presentinvention.

A “treatment effect” or “therapeutic effect” is manifested if there is achange in the condition being treated, as measured by the criteriaconstituting the definition of the terms “treating” and “treatment.”There is a “change” in the condition being treated if there is at least10% improvement, preferably at least 25%, more preferably at least 50%,even more preferably at least 75%, and most preferably at least 100%.The change can be based on improvements in the severity of the treatedcondition in an individual, or on a difference in the frequency ofimproved conditions in populations of individuals with and withouttreatment with the therapeutic compositions with which the compositionsof the present invention are administered in combination. A “therapeuticcomposition” is a composition administered to achieve a treatment ortherapeutic effect.

The term “enhancing,” and variations thereof, as used in thisspecification, refers to an increase in the therapeutic effects of acomposition above those normally obtained when the therapeuticcomposition is administered without the compositions of this invention.“An increase in the therapeutic effects” is manifested when there is anacceleration and/or increase in intensity and/or extent of thetherapeutic effects obtained with a therapeutic composition. It alsoincludes extension of the longevity of therapeutic benefits. It can alsomanifest where a lower amount of the therapeutic composition is requiredto obtain the same benefits and/or effects when it is co-administeredwith compositions provided by the present invention as when a higheramount of the therapeutic composition is administered alone. Theenhancing effect preferably, but not necessarily, results in treatmentof acute symptoms for which the therapeutic composition alone is noteffective or is less effective therapeutically. Enhancement is achievedwhen there is at least a 10% increase in the therapeutic effects when acomposition of the present invention is co-administered with atherapeutic composition compared with administration of the therapeuticcomposition alone. Preferably the increase is at least 25%, morepreferably at least 50%, even more preferably at least 75%, mostpreferably at least 100%.

An “effective amount” is an amount of a composition or substance(s)sufficient to enhance the effects of a therapeutic composition after oneor more administrations of that amount. An effective amount can beadministered in one administration, or through multiple administrationsof an amount that total an effective amount, preferably within a 24-hourperiod. It can be determined using standard clinical procedures fordetermining appropriate amounts and timing of administration. It isunderstood that the “effective amount” can be the result of empiricaland/or individualized (case-by-case) determination on the part of thetreating health care professional and/or individual.

“Co-administering” or “co-administration” of compositions, as usedherein, refers to the administration of a composition of the presentinvention and a therapeutic composition within a certain time period.The time period is preferably 12 hours, more preferably 6 hours, stillmore preferably 3 hours. These terms most preferably mean thecompositions are administered together.

“Blood circulation,” as used herein, generally refers to the course ofthe blood from the heart through the arteries, capillaries, and veinsback again to the heart. “Microcirculation,” as used herein, refers tothe circulation of blood in and/or through microvessels (such ascapillaries) and/or circulation of blood within a tissue/organ. Bloodcirculation or microcirculation is “enhanced” when at least one of thecriteria that define blood circulation and/or microcirculation isenhanced. These criteria are known in the art, for example, plasmaviscosity, blood pressure and blood viscosity. There is enhancement ofany of these criteria when there is preferably at least 10%, morepreferably at least 30%, even more preferably at least 50%, and mostpreferably at least 75% increase in the measurement of any of thesecriteria.

“Metabolism,” “cellular metabolism,” and “intracellular metabolism,” asused herein, refers to metabolic reactions and/or processes in the body,as understood in the art. It generally refers to the sum of the chemicaland/or physical changes occurring in tissue, consisting of anabolism(those reactions that convert small molecules into large) and catabolism(those reactions that convert large molecules into small), includingboth endogenous large molecules as well as biodegradation ofxenobiotics. Metabolism, cellular metabolism, and intracellularmetabolism is “enhanced” when at least one of the criteria that definemetabolism is enhanced. These criteria are known in the art, forexample, production rate/level of pyruvate, acetyl CoA, and adenosinetriphosphate. There is enhancement of any of these criteria when thereis preferably at least 10%, more preferably at least 30%, even morepreferably at least 50%, and most preferably at least 75% increase inthe measurement of any of these criteria.

“Individual,” as used herein, refers to a vertebrate, preferably amammal, more preferably a human.

A “botanical group,” as used herein, refers to a group of botanicalentities that are capable of providing similar physiological effect(s)in the compositions of the invention. These botanical entities may ormay not belong to the same botanical classification (such as genus,family).

“Xuejie,” as used herein, refers to extracts of xuejie. It is also knownas sanguis draconis and Daemonorops droco B1. A member of the botanicalgroup Daemonorops is a substance that is capable of providing a similarphysiological effect(s) as that provided by xuejie in the compositionsof the invention, and is preferably selected from a group comprisingSanguis draconis Daemonorops droco B1.; Daemonorops draco B1 (xuejie );Dracaena cambodiana Pierre; Dracaena cinnabari Balf; Dracaena dracoLinn.; Dracaena schizantha Baker; Dracaena dihynophyllus; Dracaenamicracanthus Becc.; Dracaena propinqus Becc.; Dracaena draconcellusBecc.; Dracaena motleyi Becc.; Dracaena sparsiflorus Becc.; Pterocarpusdraco Linn.; Croton draco Schlecht; Croton hibiscifolius kunth; Crotonsanguifluus H. B. et K Nov.; Croton gossypiifolius Vahl.

“Yanhusuo,” as used herein, refers to extracts of yanhusuo. It is alsoknown as Rhizoma corydalis yanhusuo and Corydalis yanhusuo W. T. Wang. Amember of the botanical group Corydalis is a substance that is capableof providing a similar physiological effect(s) as that provided byyanhusuo in the compositions of the invention, and is preferablyselected from a group comprising Rhizoma corydalis yanhusuo; Corydalisyanhusuo W. T. Wang.; Corydalis yanhusuo W. T. Wang (yanhusuo);Corydalis amabilis Migo; Corydalis amabigua Cham. et Schlecht. Varamurensts Maxim; Corydalis turtschaninovii Bess.; Corydalisturtschaninovii f. yanhusuo; Corydalis schangini (Pall.) B.; Corydalisglaucescens Rgl.; Corydalis ledebouriana Kar. Et Kir.

“Baishaoyao,” as used herein, refers to extracts of baishaoyao. It isalso known as Radix paeoniae lactiflorae and paeonia lactiflora Pall. Amember of the botanical group Paeonia is a substance that is capable ofproviding a similar physiological effect(s) as that provided bybaishaoyao in the compositions of the invention, and is preferablyselected from a group comprising Radix paeoniae lactiflorae; Radixpaeoniae rubra; Radix paeoniae veitchii; Paeonia lactiflora Pall;Paeonia albriflora Pall; Paeonia veitchii Lynch; Paeonia lactifloraPall. Var. trichocarpa (Bunge) Stem.; Paeonia obovata. Maxim; Paeoniaanomala; Paeonia hybrida Pall; Paeonia veitchii var woodwardii; Paeoniaedulis (Salisb.); Paeonia officinalis Thunb.

“Shanqi,” as used herein, refers to extracts of shanqi. It is also knownas Radix Notoginsheng and Panax notoginsheng (Burk.) F. H. Chen. Amember of the botanical group Panax is a substance that is capable ofproviding a similar physiological effect(s) as that provided by shanqiin the compositions of the invention, and is preferably selected from agroup comprising Radix notoginsheng; Panax notoginsheng (Burk.) F. H.Chen.; Panax notoginseng (Burk.) F. H. Chen (Shanqi); Panaxpseudo-ginseng Wall.var.notoginseng (Burk) Hoo et Tseng; Panax ginsengC. A. Mey (P.schinseng Nees); Panax guinquefolium L.; Radix ginseng;Panax ginseng C. A. Mey; Panax schin-seng Nees; Panax schinseng.; Panaxschinseng; Panax pseudoginseng; Panax pseudoginseng japonicus (C. A.Mey.) Hoo.&Tseng.; Panax repens. Max.; Panax pseudoginseng japonicus;Panax pseudoginseng ssp. Japonicus; Panax pseudoginseng subsp.; Panaxjaponicus; Panax pseudoginseng var. japonicus; Panax pseudo-ginseng;Panax ginseng; Panax schinseng Acanthopanax sentocosus (Rupr. etMaxim.); Eleutherococus senticosus (Rupr. et Maxim.).; Eleutherococussenticosus; Acanthopanax senticosus; Acanthopanax seticosus Harms;Acantherococus senticocus (Rupr.et.Maxim) Harms.; Eleutherococussenticocus (Rupr. Et Maxim) Maxim.; Echinopanax elatus Nakai; Hederasenticosa.

“Gancao,” as used herein, refers to extracts of gancao. It is also knownas Radix glycyrrhizae uralensis, Glycyrrhiza uralensis Fischer orlicorice root. A member of the botanical group glycyrrhiza is asubstance that is capable of providing a similar physiological effect(s)as that provided by gancao in the compositions of the invention, and ispreferably selected from a group comprising Radix glycyrrhizaeuralensis; Glycyrrhiza uralensis Fischer; Glycyrrhiza uralensis Fisch(Gan cao); Glycyrrhiza glabra L.; Glycyrrhizainflata Batal.;Glycyrrihiza korshiskyi G. Hrig.; Glycyrrhiza aspera Pall; Glycyrrhizayunnanensis Cheng f. et L. K. Tai.; Glycyrrhiza malensis.

“White willow bark,” as used herein, refers to extracts of white willowbark. It is also known as Saliz alba caertilea.

“Black cohosh root,” as used herein, refers to extracts of black cohoshroot. It is also known as rhizome of Cimicifuga racemosa or Cimicifugaracemosa. A member of the botanical group Cimicifuga is a substance thatis capable of providing a similar physiological effect(s) as thatprovided by black cohosh root in the compositions of the invention, andis preferably selected from a group comprising Cimicifuga racemosa;Cimicifuga cordifolia; Cimicifuga racemosa var. cordifolia; Cimicifugaheracleifolia Komar.; Cimicifuga dahurica (Turcz) Maxim; Cimicifugafoetida L.; Actaea racemosa.

“L-carnitine,” as used herein, refers to the biochemical molecule knownas such by persons of skill in the art. It is generally known as azwitterionic compound formed from lysine. It also refers to relatedmolecules such as L-acetyl-carnitine.

“Vitamin C,” as used herein, refers to ascorbic acid and salts thereof.

“Vitamin E,” as used herein, refers to D alpha-tocopherol, preferably insuccinate form.

“Zinc,” as used herein, refers to the form(s) of the mineral known topersons of skill in the art to be therapeutically effective in the bodyof the individual. It is preferably provided as zinc gluconate.

“Selenium,” as used herein, refers to the form(s) of the mineral knownto persons of skill in the art to be therapeutically effective in thebody of the individual. It is preferably provided as selenium aminoate.

“Extract,” as used herein, refers to the substances obtained from thespecified source plant, or parts thereof (for e.g., root, bark, leaves).Any method of extraction that yields extracts that retain the biologicalactivity of the substances contained in the extract source can be usedto produce extracts used in this invention. Preferably, the ingredientsof the compositions of the present invention are extracted as an aqueoussolution. The extraction is preferably performed under conditions ofhigh pressure, preferably from 0.5 to 12 bar, more preferably 1 to 10bar, most preferably 3 to 7 bar, and preferably at elevated temperatures(preferably within a range of 15° C. to 120° C., more preferably 30° C.to 100° C., most preferably 45° C. to 75° C.). The extract is preferablytreated to yield a form suitable for mixing of two or more substances.The form is preferably a dried powder. The powder form is yielded frompreferably at least about a 1:10, more preferably at least about a 1:8,most preferably at least about a 1:5 concentrate of the startingsolution. Concentration to powder form is preferably achieved byevaporation to yield a dried powder form. The extracts used in thisinvention can also be obtained from commercial sources such as Sun TenLaboratories (Irvine, Calif.), Qualiherb (Cerritos, Calif.), Mayway(Oakland, Calif.), Ming Tong Herb (Oakland, Calif.) and Acta (Sunnyvale,Calif.). It is understood that any method or conditions known in the artto yield extracts comparable in effectiveness in enhancing therapeuticeffects to those produced by the preceding preferred extraction methodcan be used for the purposes of this invention.

Formulation of the Composition

Each substance contained in the compositions provided by this inventionis provided in an amount that lies within specific quantitative rangesherein disclosed to be effective for enhancing the therapeutic effectsof a therapeutic composition.

According to the present invention, an effective amount of a compositioncomprises preferably from 100 to 1500 mg, more preferably 300 mg to.1200 mg, most preferably 600 mg to 900 mg of a member of the botanicalgroup Daemonorops (such as xuejie ); and/or preferably 50 mg to 1000 mg,more preferably 200 mg to 800 mg, most preferably 400 mg to 600 mg of amember of the botanical group Corydalis (such as yanhusuo).

In the various embodiments of the invention, the compositions furthercomprise preferably from 50 mg to 1000 mg, more preferably 200 mg to 800mg, most preferably 400 mg to 600 mg of a member of the botanical groupPaeonia (such as baishaoyao); preferably 200 mg to 3000 mg, morepreferably 500 mg to 2000 mg, most preferably 800 mg to 1500 mg of amember of the botanical group Panax (such. as shanqi); preferably 50 mgto 1000 mg, more preferably 200 mg to 800 mg, most preferably 400 mg to600 mg of a member of the botanical group glycyrrhiza (such as gancao);preferably 5 mg to 150 mg, more preferably 10 mg to 120 mg, mostpreferably 75 mg to 100 mg white willow bark; preferably 5 mg to 150 mg,more preferably 40 mg to 120 mg, most preferably 75 mg to 100 mg of amember of the botanical group Cimicifuga (such as black cohosh root);preferably 30 mg to 600 mg, more preferably 120 mg to 500 mg, mostpreferably 250 mg to 400 mg,L-carnitine; preferably 10 mg to 250 mg,more preferably 80 mg to 300 mg, most preferably 120 mg to 200 mgvitamin E; and/or preferably 20 mg to 400 mg, more preferably 80 mg to300 mg, most preferably 120 mg to 200 mg vitamin C.

Thus, for example, a composition may comprise preferably from 100 to1500 mg, more preferably 300 mg to 1200 mg, most preferably 600 mg to900 mg of a member of the botanical group Daemonorops (such as xuejie),and preferably 200 mg to 3000 mg, more preferably 500 mg to 2000 mg,most preferably 800 mg to 1500 mg: of a member of the botanical groupPanax (such as shanqi). In another example, a composition comprisespreferably 50 mg to 1000 mg, more preferably 200 mg to 800 mg, mostpreferably 400 mg to 600 mg of a member of the botanical group Corydalis(such as yanhusuo), and preferably 200 mg to 3000 mg, more preferably500 mg to 2000 mg, most preferably 800 mg to 1500 mg of a member of thebotanical group Panax (such as shanqi).

Selection of suitable members of a particular botanical group to beincluded in a composition can be achieved using methods known in theart. For example, a suitable member of the botanical group Panax wouldbe expected to be capable of providing a similar physiological effect(s)as that provided by shanqi in a composition of the invention. Such amember can be selected based on, for example, whether it is known, shownand/or suspected to possess said similar physiological effect(s). Thus,for example, a determination of whether a candidate substance can be amember of the botanical group Panax can be done based on, for example, asimilar pharmacological or medicinal classification for both thecandidate substance and shanqi. However, the activity and/or functionprovided by a particular substance, such as shanqi, need not beidentified or specified. A determination of whether a candidatesubstance can be a member of a particular botanical group, for examplethe Panax group, can also be empirical, for example, by substitutingsaid candidate substance for shanqi in a composition, and assessing therelevant therapeutic effect(s)

of the composition. Such a determination can be done using methods andtechniques known in the art.

According to this invention, the compositions can be formulated inwhatever form that retains the efficacy of the compositions forenhancing the therapeutic effects of another composition. Preferably,the compositions are packaged in the form of capsules. The capsules arepreferably of size “0”, “00”, “000”, “1”, “2”, “3” or “4.” A preferredmethod for packaging into capsules involves mixing substances (extracts,vitamin and minerals) that are preferably in powder form. The substancesare preferably mixed to at least 30%, more preferably to at least 60%,even more preferably to at least 90% mixture consistency, and mostpreferably to homogeneity. The substances in powder form are provided inthe initial mixture at ratios according to the effective quantitiesdisclosed above. Methods for mixing the substances are known in the art,including, but not limited to, stirring, agitation or vibration achievedmanually or through the aid of a machine. A preferred mixing machine isa V-mixer, preferably of 100 to 1400-liter size, more preferably of 150to 1300-liter size, and most preferably of 200 to 1200-liter size.Preferably, the resulting powder mixture is filtered to screen outparticulates (i.e., anything that a person of skill in the art wouldrecognize to be larger than powder size). A preferred filter is a{fraction (1/20)}-inch particle size filter. Preferably, the filteredmixture is packaged into capsules according to the weight desired foreach capsule. Preferably, the capsule is of size “00”. The weight ofmixture per capsule is preferably from 5 mg to 1000 mg, more preferably100 mg to 800 mg, even more preferably 400 mg to 700 mg. It isunderstood that other physical forms of the compositions of thisinvention suitable for administration to an individual can also be used,including, for example, tablets, salves or liquids, as long as thecompositions can be delivered to the target tissues in the body wherethe compositions in the preferred form described above exert theireffects.

The ingredients of the compositions can be mixed with pharmaceuticallyacceptable solvents, excipients and/or filler substances. Thesematerials are known in the art, and are described in sources such asRemington's Pharmaceutical Sciences, 18th Edition, Mack Publishing(1990).

Combining Compositions of the Present Invention with a TherapeuticComposition

Compositions in any of the physical forms described above can beadministered by any method known to one of skill in the art, but oraladministration is preferred. The compositions are preferablyadministered in capsule form.

An effective amount of a composition is provided preferably in from 1 to8 administrations, more preferably in from 2 to 6 administrations, andmost preferably in from 3 to 5 administrations. Administration of aneffective amount is preferably completed within 24 hours. A compositioncan be ingested alone, or with any other substance, such as a liquid,that aids ingestion of the compositions. Ingestion of the compositionscan be before or after food consumption. The compositions of the presentinvention can be combined with any therapeutic composition to enhancethe effects of the therapeutic composition in treating diseases ordiscomfort conditions.

In preferred embodiments, the present compositions are combined withcompositions that are effective in treating eye discomfort syndromes,pains and/or discomfort in joints such as the wrist, pains and/ordiscomfort in the neck and/or shoulder, or pains and/or discomfort inthe back and leg. We have discovered that the compositions of thepresent invention are particularly effective in enhancing thetherapeutic effects of the compositions disclosed in co-pending patentapplications entitled “Compositions And Methods For Treating EyeDiscomfort” (U.S. provisional Application Ser. No. 60/208,783; U.S.patent application Ser. No. 09/872,375, filed even date herewith);“Compositions And Methods For Treating Hand And Wrist Discomfort” (U.S.provisional Application Ser. No. 60/208,991; U.S. patent applicationSer. No. 09/873,175, filed even date herewith); “Compositions andMethods For Treating Neck And Shoulder Discomfort” (U.S. provisionalApplication Ser. No. 60/208/797; U.S. patent application Ser. No.09/872,368, filed even date herewith); and “Compositions and Methods ForTreating Back And Leg Discomfort” (U.S. provisional Application Ser. No.60/208,793; U.S. patent application Ser. No. 09/872,609, filed even dateherewith), all of which are hereby in their entirety incorporated byreference. The present compositions enhance the therapeutic effects ofthese compositions for treating conditions such as eye discomfortsyndromes, wrist strain or pain, neck or shoulder pain, and back or legpain. Without wishing to be bound by theory, the compositions of thepresent invention enhance therapeutic effects by relaxing muscles andtendons, activating the flow of Qi and blood in the meridian andcollaterals according to Chinese medicine, relieving rigidity of musclesand activating collaterals and promoting blood circulation, enrichingblood and nourishing muscles and tendons, and arresting bleeding byremoval of stasis, thereby promoting the delivery of the therapeuticcompositions to target tissues when the therapeutic compositions areco-administered with the present compositions.

Other medical conditions for which the compositions of the presentinvention are particularly useful include post-trauma muscle spasms,bleeding (internal and external), sciatic pain, swelling and bleedingdue to injury and bruising, inflammatory conditions, general andspecific pain conditions. The present compositions enhance the efficacyof compositions used to treat these conditions.

The preferred timing of co-administration is administration of thecompositions of this invention at the same time as the administration ofthe therapeutic compositions. However, the timing of co-administrationcan be varied according to the needs of the individual, or in accordancewith the empirical determination or experience of the health careprofessional or individual.

EXAMPLES Example 1

An Illustrative Example of the Formulation of a Single “00” Capsule, andthe Production Thereof

A composition shown to enhance the effects of a therapeutic compositionfor treating neck and shoulder pains contained substances in theindicated quantities as listed in Table 1.

TABLE 1 SUBSTANCE [Commercial Source] AMOUNT (mg) Xuejie [Min Tong Herb,Oakland, CA] 133 Yanhusuo [Mayway, Oakland, CA] 83 Baishaoyao[Qualiherb, Cerritos, CA] 83 Shanqi [Sun Ten, Irvine, CA] 250 Gancao[Qualiherb, Cerritos, CA] 83 White willow bark [Acta, Sunnyvale, 10 CA]Black cohosh root [Acta, Sunnyvale, 10 CA] L-carnitine [Acta, Sunnyvale,CA] 50 Vitamin E (D Alpha-Tocopherol 21.19 succinate) [Acta, Sunnyvale,CA] Vitamin C [Acta, Sunnyvale, CA] 30

Capsules containing the composition above were manufactured according tothe method used by the commercial manufacturer, Acta (Sunnyvale,Calif.). Briefly, the substances listed above, in powder form andobtained from the commercial sources indicated, were mixed in inputamounts in accordance to the ratio of the substances in the compositionas a whole. Mixing was accomplished with a V-mixer, grinding for 15 to30 minutes, at a speed of 15 to 30 rpm (rounds per minute), to produce ahomogenous mixture of the input substances. Particulates (non-powderforms) were then filtered out with a {fraction (1/20)}-inch particlesize filter that separated particulates from the powder. 671 mg of thefiltered mixture was then packaged into each size “00” capsule.

Example 2

Illustrative Example of Enhancement of Therapeutic Effects of aComposition for Treating Neck or Shoulder Discomfort

11 individuals with neck or shoulder pain symptoms were treated with thecomposition exemplified in Example 1 in combination with the compositionset forth in Table 2. The composition of Table 2 is exemplified asExample 1 of co-pending patent application entitled “Compositions andMethods For Treating Neck And Shoulder Discomfort” (which is herebyincorporated herein by reference in its entirety). The individuals wereinstructed to fill out a clinical questionnaire to assess efficacy oftreatment with these compositions over time. They were instructed toassess frequency of pain (e.g., occasional, intermittent, or constant)as a primary criterion for pain severity. They were administered thecompositions for between 3 days and 3 weeks, at a daily dosage of from 2to 9 capsules of the composition of Table 2, and at a daily dosage offrom 1 to 9 capsules of the composition of Example 1.

TABLE 2 A Composition For Treating Neck And Shoulder DiscomfortSUBSTANCE [commercial source] AMOUNT (mg) Huangqi [Mayway, Oakland, CA]33 Dangquiwei [Mayway, Oakland, CA] 33 Weilingxian [ Qualiherb,Cerritos, CA] 67 Gegen [Qualiherb, Cerritos, CA] 167 Guizi [Qualiherb,Cerritos, CA] 167 Baishaoyao [Qualiherb, Cerritos, CA] 167 Gancao[Qualiherb, Cerritos, CA] 17 Dazao [Mayway, Oakland, CA] 17 Bilberry[Acta, Sunnyvale, CA] 10 Ginger [Qualiherb, Cerritos, CA] 17 Vitamin B-1(thiamine) [Acta, 5 Sunnyvale, CA] Vitamin B-2 (riboflavin) [Acta, 5Sunnyvale, CA] Vitamin B-6 (pyridoxine) [Acta, 15 Sunnyvale, CA] VitaminB-12 (cobalamin) [Acta, 0.0125 Sunnyvale, CA] Vitamin C (ascorbic acid)[Acta, 30 Sunnyvale, CA] Vitamin E (D alpha-tocopherol 21.19 succinate)[Acta, Sunnyvale, CA] White willow bark [Acta, Sunnyvale, 10 CA]Quercitin [Acta, Sunnyvale, CA] 25 Selenium aminoate [Acta, Sunnyvale,20 CA]

Severity of neck pain was graded on a scale of 0 to 10. 0 was defined asnormal neck condition and 10 was defined as severe pain. The resultsshowed a clear and significant decrease in severity, and in some casescomplete clearance, of pain by the end of the study. By comparing theseresults to the results expected from a study wherein individuals areadministered the composition of Table 2 alone, it would be clear thatthe composition of Example 1 enhances the therapeutic effects of thecomposition of Table 2 in treating neck pain.

Severity of shoulder pain was graded on a scale of 0 to 10. 0 wasdefined as normal shoulder condition and 10 was defined as severe pain.The results showed a clear and significant decrease in severity, and insome cases complete clearance, of pain by the end of the study. Bycomparing these results to the results expected from a study whereinindividuals are administered the composition of Table 2 alone, it wouldbe clear that the composition of Example 1 enhances the therapeuticeffects of the composition of Table 2 in treating shoulder pain.

It is understood that the enhancing effect of the compositions of thepresent invention can be demonstrated for any therapeutic compositionusing any study protocol similar to the one described in this Example.

Example 3

Illustrative Example of Enhancement of Therapeutic Effects of aComposition for Treating Hand or Wrist Discomfort

An individual who suffered two separate bouts of wrist pain was treatedduring the course of one bout with the composition set forth in Table 3(Bout A), and during the course of the other bout with the compositionof Table 3 in combination with the composition exemplified in Example 1of the instant specification (Bout B). The composition of Table 3 isexemplified as Example 1 of co-pending patent application entitled“Compositions And Methods For Treating Hand And Wrist Discomfort” (whichis hereby incorporated herein by reference in its entirety). In Bout A,5 dosages of 2 capsules per dosage, followed by 7 dosages of 1 capsuleper dosage, of the composition of Table 3 were administered. In Bout B,the same dosage amounts were administered for the same duration, exceptthat the composition of Example 1 of the instant specification wasco-administered (simultaneously) at 2 capsules per dosage for the first5 dosages, and at 1 capsule per dosage for the following 3 dosages.

TABLE 3 A Composition For Treating Hand And Wrist Discomfort SUBSTANCE[commercial source] AMOUNT (mg) Baishaoyao [Qualiherb, Cerritos, CA]33.3 Fangfeng [Qualiherb, Cerritos, CA] 33.3 Guizi [Qualiherb, Cerritos,CA] 50 Honghua [Qualiherb, Cerritos, CA] 33.3 Chuanxiong [Qualiherb,Cerritos, CA] 50 Yuanhusuo [Mayway, Oakland, CA] 50 Dangquiwei [Mayway,Oakland, CA] 50 Gancao [Qualiherb, Cerritos, CA] 33.3 Ginger [Qualiherb,Cerritos, CA] 33.3 Huangqi [Mayway, Oakland, CA] 1.33 Sangzhi[Qualiherb, Cerritos, CA] 66.7 Yinyanghuo [Qualiherb, Cerritos, CA] 33.3Weilingxian [Mayway, Oakland, CA] 66.7 Dazao [Mayway, Oakland, CA] 16.7Vitamin B-1 (Thiamine) [Acta, 4.2 Sunnyvale, CA] Vitamin B-2(Riboflavin) [Acta, 4.2 Sunnyvale, CA] Vitamin B-3 (Niacin) [Acta,Sunnyvale, 8.3 CA] Vitamin B-5 (Pantothenic acid) [Acta, 4.2 Sunnyvale,CA] Vitamin B-6 (pyridoxine) [Acta, 33 Sunnyvale, CA] Vitamin C(ascorbic acid) [Acta, 100 Sunnyvale, CA] Vitamin E (D alpha-tocopherol14.1 succinate) [Acta, Sunnyvale, CA] Beta-carotene [Acta, Sunnyvale,CA] 7.5 Zinc gluconate [Acta, Sunnyvale, CA] 21 Quercetin [Acta,Sunnyvale, CA] 8.3 Selenium aminoate [Acta, Sunnyvale, 6.7 CA] Riceflour powder [Acta, Sunnyvale, 10 CA] Magnesium stearate NT [Acta, 10Sunnyvale, CA]

Prior to administration of the composition(s), the individual was askedto rate the severity of her symptoms on a scale of 0 to 5, 0 beingnormal condition and 5 being severe pain. Subsequently, the individualwas asked to assess her symptoms within 4 hours after eachadministration of the composition(s). The individual was instructed toassess frequency of pain (e.g., occasional, intermittent, or constant)as a primary criterion for pain severity. If administration occurred atbedtime, symptoms were assessed the following morning.

Results of the study are provided in Table 4.

TABLE 4 Severity of Wrist Pain Dosage No. 0 1 2 3 4 5 6 7 8 9 10 11 12Bout A 4 4 4 4 4 4 4 4 4 4 4 3 3 (severity) Bout B 4 4 4 4 3 2 1 1 0.5 00 0 0 (severity)

The data show a clear and significant enhancement of therapeutic effectwhen the composition of Example 1 in the instant specification wasco-administered with the composition for treating wrist pain.

Example 4

Illustrative Example of Enhancement of Therapeutic Effects of aComposition for Treating Eye Discomfort

A randomized, double-blinded and controlled study is performed.Individuals suffering from eye discomfort such as dry eyes are dividedinto three groups. Individuals in the first group are administered thecomposition set forth in Table 5. The composition of Table 5 isexemplified as Example 1 of co-pending patent application entitled“Compositions And Methods For Treating Eye Discomfort” (which is herebyincorporated herein by reference in its entirety). Individuals in thesecond group are administered the composition exemplified in Example 1of the instant specification. Individuals in the third group areco-administered the compositions administered to the individuals of thefirst and second group. Preferably, a fourth group is included in whichindividuals are administered a placebo that does not contain any of thesubstances found in the compositions administered to the first andsecond group.

TABLE 5 A Composition For Treating Eye Discomfort SUBSTANCE [Commercialsource] AMOUNT (mg) Fuling [Qualiherb, Cerritos, CA] 16.7 Jueminzi[Qualiherb, Cerritos, CA] 8.3 Sang ye [Qualiherb, Cerritos, CA] 33.3Shanyao [Qualiherb, Cerritos, CA] 16.7 Shanzhuyu [Mayway, Oakland, CA]16.7 Shudihaung [Qualiherb, Cerritos, CA] 100.0 Bilberry [Acta,Sunnyvale, CA] 16.7 Danshen [Qualiherb, Cerritos, CA] 16.7 Gouqizhi[Qualiherb, Cerritos, CA] 100.0 Juhua [Qualiherb, Cerritos, CA] 66.7Baijili [Qualiherb, Cerritos, CA] 16.7 Beta-carotene [Acta, Sunnyvale,CA] 22.5 Copper gluconate [Acta, Sunnyvale, CA] 7.1 Gujincao [Qualiherb,Cerritos, CA] 8.3 Magnesium stearate NF [Acta, 10.0 Sunnyvale, CA]Mudanpi [Qualiherb, Cerritos, CA] 16.7 Rice flour powder [Acta,Sunnyvale, CA] 8.3 Seleniuum aminoate [Acta, Sunnyvale, 6.7 CA] VitaminB-2 (riboflavin) [Acta, 5.0 Sunnyvale, CA] Vitamin C (ascorbic acid)[Acta, 66.7 Sunnyvale, CA] Vitamin E (D Alpha-tocopherol 76.0 succinate)[Acta, Sunnyvale, CA] Zexie [Acta, Sunnyvale, CA] 16.7 Zinc gluconate[Acta, Sunnyvale, CA] 57.7

Individuals in the first group are daily administered from 1 to 6capsules of the composition of Table 5. Individuals in the second groupare daily administered from 1 to 6 of the capsules of Example 1 of theinstant specification. Individuals in the third group are dailyadministered the combined dosages of the individuals of the first andsecond group.

At least 20 individuals are tested, randomly assigned in approximatelyequal number to the various groups. Individuals are evaluated to sufferfrom a particular eye discomfort symptom, such as dry eyes.

The study is carried out for at least 1 week. During the treatmentcourse, a dosage amount selected from the range of 1 to 6 capsules ofeach composition is administered to each individual once or multipletimes daily, not exceeding 6 capsules of each composition per day.Capsules are administered before or after food-consumption.

A clinical questionnaire is used to evaluate individuals' eye discomfortsymptoms. A clinical coordinator and/or physician evaluates theindividuals' eye discomfort symptoms and fills out the questionnaire.Evaluations can be performed daily, or more or less frequently dependingon statistical or clinical (ability to detect or track symptomaticimprovements) need.

Assessment of symptoms is divided into 4 grades: (1) clinical cure, asdefined as free of symptoms; (2) significant efficacy, as defined assignificantly improved symptoms (e.g., reduction of more than 3 pointson any one of discomfort scoring scales); (3) efficacy, as defined aspartially improved (e.g. reduction of more than 1 point on any one ofdiscomfort scoring scales); and (4) non-efficacy, as defined as noimprovement in symptoms.

The results of the groups are compared to assess any enhancedtherapeutic effects due to the co-administration of the compositionexemplified in Example 1.

Example 5

Illustrative Example of Enhancement of Therapeutic Effects of aComposition for Treating Wrist Discomfort

A randomized, double-blinded and controlled study is performed.Individuals suffering from wrist discomfort such as wrist pain aredivided into three groups. Individuals in the first group areadministered the composition set forth in Table 3. Individuals in thesecond group are administered the composition exemplified in Example 1of the instant specification. Individuals in the third group areco-administered the compositions administered to the individuals of thefirst and second group. Preferably, a fourth group is included in whichindividuals are administered a placebo that does not contain any of thesubstances found in the compositions administered to the first andsecond group.

Individuals in the first group are daily administered from 1 to 6capsules of the composition of Table 3. Individuals in the second groupare daily administered from 1 to 6 of the capsules of Example 1 of theinstant specification. Individuals in the third group are dailyadministered the combined dosages of the individuals of the first andsecond group.

At least 20 individuals are tested, randomly assigned in approximatelyequal number to the various groups. Individuals are evaluated to sufferfrom a particular wrist discomfort symptom, such as wrist pain.

The study is carried out for at least 1 week. During the treatmentcourse, a dosage amount selected from the range of 1 to 6 capsules ofeach composition is administered to each individual once or multipletimes daily, not exceeding 6 capsules of each composition per day.Capsules are administered before or after food consumption.

A clinical questionnaire is used to evaluate individuals' wristdiscomfort symptoms. A clinical coordinator and/or physician evaluatesthe individuals' wrist discomfort symptoms and fills out thequestionnaire. Evaluations can be performed daily, or more or lessfrequently depending on statistical or clinical (ability to detect ortrack symptomatic improvements) need.

Assessment of symptoms is divided into 4 grades: (1) clinical cure, asdefined as free of symptoms; (2) significant efficacy, as defined assignificantly improved symptoms (e.g., reduction of more than 3 pointson any one of discomfort scoring scales); (3) efficacy, as defined aspartially improved (e.g. reduction of more than 1 point on any one ofdiscomfort scoring scales); and (4) non-efficacy, as defined as noimprovement in symptoms.

The results of the groups are compared to assess any enhancedtherapeutic effects due to the co-administration of the compositionexemplified in Example 1.

Example 6

Illustrative Example of Enhancement of Therapeutic Effects of aComposition for Treating Back and Leg Discomfort

A randomized, double-blinded and controlled study is performed.Individuals suffering from back or leg discomfort such as back or legpain are divided into three groups. Individuals in the first group areadministered the composition set forth in Table 6. The composition ofTable 6 is exemplified as Example 1 of co-pending patent applicationentitled “Compositions And Methods For Treating Back And Leg Discomfort”(which is hereby incorporated herein by reference in its entirety).Individuals in the second group are administered the compositionexemplified in Example 1 of the instant specification. Individuals inthe third group are co-administered the compositions administered to theindividuals of the first and second group. Preferably, a fourth group isincluded in which individuals are administered a placebo that does notcontain any of the substances found in the compositions administered tothe first and second group.

TABLE 6 A Composition For Treating Back And Leg Discomfort SUBSTANCE[commercial source] AMOUNT (mg) Duzhong [Mayway, Oakland, CA] 33Huainiuxi [Qualiherb, Cerritos, CA] 33 Jixueteng [Qualiherb, Cerritos,CA] 117 Qiannianjian [Qualiherb, Cerritos, CA] 33 Rougui [Qualiherb,Cerritos, CA] 50 Xiquancao [Qualiherb, Cerritos, CA] 133 Jinyingzi[Mayway, Oakland, CA] 33 Tougucao [Qualiherb, Cerritos, CA] 33 Duhuo[Qualiherb, Cerritos, CA] 100 Weilingxian [Mayway, Oakland, CA] 67Shenjincao [Qualiherb, Cerritos, CA] 17 Vitamin B-1 [Acta, Sunnyvale,CA] 5 Vitamin B-2 [Acta, Sunnyvale, CA] 5 Vitamin B-6 [Acta, Sunnyvale,CA] 15 Vitamin B-12 [Acta, Sunnyvale, CA] 0.0125 Vitamin C (ascorbicacid) [Acta, 30 Sunnyvale, CA] Vitamin E (D Alpha-Tocopherol) [Acta,21.19 Sunnyvale, CA] Devil's Claw [Acta, Sunnyvale, CA] 10 Black cohosh[Acta, Sunnyvale, CA] 10 Selenium [Acta, Sunnyvale, CA) 20

Individuals in the first group are daily administered from 1 to 6capsules of the composition of Table 6. Individuals in the second groupare daily administered from 1 to 6 of the capsules of Example 1 of theinstant specification. Individuals in the third group are dailyadministered the combined dosages of the individuals of the first andsecond group.

At least 20 individuals are tested, randomly assigned in approximatelyequal number to the various groups. Individuals are evaluated to sufferfrom a particular back or leg discomfort symptom, such as back or legpain.

The study is carried out for at least 1 week. During the treatmentcourse, a dosage amount selected from the range of 1 to 6 capsules ofeach composition is administered to each individual once or multipletimes daily, not exceeding 6 capsules of each composition per day.Capsules are administered before or after food consumption.

A clinical questionnaire is used to evaluate individuals' back or legdiscomfort symptoms. A clinical coordinator and/or physician evaluatesthe individuals' back or leg discomfort symptoms and fills out thequestionnaire. Evaluations can be performed daily, or more or lessfrequently depending on statistical or clinical (ability to detect ortrack symptomatic improvements) need.

Assessment of symptoms is divided into 4 grades: (1) clinical cure, asdefined as free of symptoms; (2) significant efficacy, as defined assignificantly improved symptoms (e.g., reduction of more than 3 pointson any one of discomfort scoring scales); (3) efficacy, as defined aspartially improved (e.g. reduction of more than 1 point on any one ofdiscomfort scoring scales); and (4) non-efficacy, as defined as noimprovement in symptoms.

The results of the groups are compared to assess any enhancedtherapeutic effects due to the co-administration of the compositionexemplified in Example 1.

Example 7

Illustrative Example of Enhancement of Therapeutic Effects of aComposition for Treating Neck and Shoulder Discomfort

A randomized, double-blinded and controlled study is performed.Individuals suffering from neck or shoulder discomfort such as neck orshoulder pain are divided into three groups. Individuals in the firstgroup are administered the composition of Table. 2. Individuals in thesecond group are administered the composition exemplified in Example 1of the instant specification. Individuals in the third group areco-administered the compositions administered to the individuals of thefirst and second group. Preferably, a fourth group is included in whichindividuals are administered a placebo that does not contain any of thesubstances found in the compositions administered to the first andsecond group.

Individuals in the first group are daily administered from 1 to 6capsules of the composition of Table 2. Individuals in the second groupare daily administered from 1 to 6 of the capsules of Example 1 of theinstant specification. Individuals in the third group are dailyadministered the combined dosages of the individuals of the first andsecond group.

At least 20 individuals are tested, randomly assigned in approximatelyequal number to the various groups. Individuals are evaluated to sufferfrom a particular neck or shoulder discomfort symptom, such as neck orshoulder pain.

The study is carried out for at least 1 week. During the treatmentcourse, a dosage amount selected from the range of 1 to 6 capsules ofeach composition is administered to each individual once or multipletimes daily, not exceeding 6 capsules of each composition per day.Capsules are administered before or after food consumption.

A clinical questionnaire is used to evaluate individuals' neck orshoulder discomfort symptoms. A clinical coordinator and/or physicianevaluates the individuals' neck or shoulder discomfort symptoms andfills out the questionnaire. Evaluations can be performed daily, or moreor less frequently depending on statistical or clinical (ability todetect or track symptomatic improvements) need.

Assessment of symptoms is divided into 4 grades: (1) clinical cure, asdefined as free of symptoms; (2) significant efficacy, as defined assignificantly improved symptoms (e.g., reduction of more than 3 pointson any one of discomfort scoring scales); (3) efficacy, as defined aspartially improved (e.g. reduction of more than 1 point on any one ofdiscomfort scoring scales); and (4) non-efficacy, as defined as noimprovement in symptoms.

The results of the groups are compared to assess any enhancedtherapeutic effects due to the co-administration of the compositionexemplified in Example 1.

Although the foregoing invention has been described in some detail byway of illustration and example for purposes of clarity ofunderstanding, it will be apparent to those skilled in the art thatcertain changes and modifications can be practiced. Therefore, thedescription and examples should not be construed as limiting the scopeof the invention, which is delineated by the appended claims.

What is claimed is:
 1. A first composition for enhancing the therapeutic effects of a second composition, said first composition comprising xuejie, yanhusuo, baishaoyao, shanqi, gancao, white willow bark, black cohosh root, L-camitine, vitamin E and vitamin C. 